UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003574 |
|---|---|
| Receipt number | R000004058 |
| Scientific Title | Therapeutic effects of T-type and N-type calcium channel blockers on hypertensive diabetic patients with renal diseases. (TITANS Study) |
| Date of disclosure of the study information | 2010/05/06 |
| Last modified on | 2011/01/19 18:08:19 |
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Basic information
Public title
Therapeutic effects of T-type and N-type calcium channel blockers on hypertensive diabetic patients with renal diseases.
(TITANS Study)
Acronym
Therapeutic effects of T-type and N-type calcium channel blockers on hypertensive diabetic patients with renal diseases.
(TITANS Study)
Scientific Title
Therapeutic effects of T-type and N-type calcium channel blockers on hypertensive diabetic patients with renal diseases.
(TITANS Study)
Scientific Title:Acronym
Therapeutic effects of T-type and N-type calcium channel blockers on hypertensive diabetic patients with renal diseases.
(TITANS Study)
Region
| Japan |
Condition
Condition
hypertensive diabetic patients with renal diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will compare the organ-protective effects between L/T type calcium channel blocker and L/N type calcium channel blocker on hypertensive diabetic patients with renal diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Clinic blood pressure, pulse rate
2.Blood test; K+, Cr, NE, aldosterone, ACTH, cortisol, BNP
3.Urine test; albuminuria
4.Vascular test; PWV, AI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: Change already prescribed L-type calcium channel blockers to daily dosing of benidipine 8 mg daily for 24 weeks, and dosage may be modulated accroding to the clinical parameters. After benidipine treatment, change to daily dosing of cilnidipine 10mg daily for 24 weeks, and dosage may be modulated according to the clinical parameters.Target blood pressure level is below 130/80 mmHg.
Interventions/Control_2
Group B: Change already prescribed L-type calcium channel blockers to daily dosing of cilnidipine 10 mg daily for 24 weeks, and dosage may be modulated accroding to the clinical parameters. After cilnidipine treatment, change to daily dosing of benidipine 8mg daily for 24 weeks, and dosage may be modulated according to the clinical parameters.Target blood pressure level is below 130/80 mmHg.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hypertensive diabetic patients with renal diseases, who are not treaeted with L/T type nor L/N type calcium channel blockers
1. Albuminuria is over 30 mg/gCr.
2. Type 2 diabates who were diagnosed by criteria of Japan Diabetes Society.
3. SBP>=140 mmHg or DBP>=90 mmHg, or patients who are already treated with antihyperteisive agents.
Key exclusion criteria
1. Patients who are contraindicated to benidipine or cilnidipine.
2. Patients without imformed consent.
3. Inappropriate patients based on the descision by responsible doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyoshi Tojo |
Organization
The Jikei University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
+81-3-3815-5411(35013)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 06 | Day |
Last modified on
| 2011 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004058
